Gamp | 5 Categories Of Software

This category is for software that is custom-built for a specific organization. The code is written specifically for the user, or significant modifications are made to a commercial product.

Standard lab balances with a serial output, off-the-shelf chart recorders, simple digital thermometers, or a basic commercial software package you install and run "as-is."

Let’s break down the four categories of GAMP 5 software. gamp 5 categories of software

This is commercial off-the-shelf software (COTS) that is used "as-is." The user cannot change the software code, nor can they configure it to alter the business process. You simply install it and use it according to the manual.

Full software development life cycle (SDLC) rigor. This includes: This category is for software that is custom-built

Are we configuring this, or just installing it? The answer will define your validation strategy.

You generally do not validate the OS itself. Instead, you qualify it. You record the version number, verify the installation was successful, and ensure basic security settings are applied (like user access controls). This is commercial off-the-shelf software (COTS) that is

This is the most common category in manufacturing and laboratory environments. It involves COTS products where the user can configure specific parameters to match their business processes, but the underlying source code remains untouched.

Custom-coded manufacturing execution logic, in-house developed Python scripts for data analysis, customized ERP modules written specifically for your site, or a mobile app coded from scratch.